Notes on Pubic Health issues

By Dr. Larry Fedewa

(Washington DC, August 4, 2020) Last week I was interviewed by my TBNRN colleague Tom Donelson (“The Donelson Files”). Tom’s interview prompted my recalling several stories of my experiences over my years as a U.S. government contractor. I have not previously discussed these impressions publicly, but Tom’s reaction has convinced me that these experiences should be discussed.

The first issue has to do with the perspective typically taken by public health experts on infectious diseases, epidemics and pandemics. Though not one of that fraternity myself, I nevertheless have had extensive experience with the profession.

For approximately twenty years in the 1990’s and 2000’s, my firm negotiated and oversaw several large contracts with various Institutes and Centers of the National Institutes of Health, at the time a $28 billion agency of the United States government, and a world leader in health sciences research.

On the list of our contracts was the largest of the 27 Institutes and Centers, the National Institute of Allergies and Infectious Diseases (NIAID), led then as now by Dr. Anthony Fauci. I knew Dr. Fauci by reputation and several personal interviews over the years.

During that same period, my firm partnered in two joint ventures with The Johns Hopkins School of Public Health, the first such program and still arguably the highest regarded school of its kind. My primary contact in those endeavors was the ever delightful and always eager to try something new, Associate Dean of the School of Public Health.

From all these experiences I derived my opinion of the “public health perspective”.  I found that the experts generally present a united front on critical topics – presumably to avoid public confusion. Those opinions tend to be “purist” approaches, meaning that their public posture is based on solely medical reasoning without regard for other possibly critical factors, such as financial, social or psychological consequences.

These other factors can set up a value judgement as to whether the damage from following the medical-only recommendation outweighs the other factors, and to what extent. The public health experts would say simply that those decisions are for others to make. Their responsibility is confined solely to the medical arena.

Thus, it was a surprise to me when the Trump Administration adopted in toto the recommendations of designated public health experts in their Task Force. I was somewhat skeptical of the “shut down” strategy in the first place.

On the topic of vaccines, I can perhaps provide some background. I first encountered the subject at a retirement cocktail party, held by my daughter, Kirsten A, Fedewa, for outgoing Secretary of Health and Human Services (HHS), Tommy Thompson, I attended with my client, Mark Schroeder, head of the federal services group for Tunnell Consulting, a distinguished firm specializing in the pharmaceutical industry. As we were introduced to the Secretary, the word “vaccines” entered the conversation. Thompson immediately called to his side HHS Chief Legal Counsel, Alex Azar, a handsome and energetic young lawyer.

 It emerged that President George W. Bush had mandated HHS to recommend a vaccine for the emerging H5N1 (“bird flu”). Secretary Thompson had assigned the task to Alex, who quickly discovered that there were NO manufacturers of vaccines currently doing business in the USA. As we later discovered, American companies had given up the product because the demand was too volatile to be done profitably. It was up to the new Secretary, Mike Leavitt, and Alex to find a solution. Cards were quickly exchanged!

In the succeeding months, Alex and I were able to schedule a meeting with the Secretary and my clients, which led to other sessions with the new executive designated to develop a vaccine industry in the United States. Eventually, our firm won the competition to assist the government in this task.

To say that the task was a daunting one is to minimize the effort. We hired an All-Star cast of recently retired “Big Pharma” executives as well as independent specialists and academics on temporary leave from their universities. Some were among the only two or three experts in the world!

The fundamental challenge was easily stated, though seemingly impossible to accomplish: to teach government employees who had no conception of profit and loss to design a program for companies whose survival depended on profitability. My responsibility was administration of the contract, which among other things included convincing penny-pinching Contract Officers that we could not attract and hold world-class talent with piker’s wages.

The result of the combined efforts of our staff and the government players was what is now known as the Biomedical Advanced Research and Development Authority (BARDA). The relevance of this background to the present is that BARDA is very active in the development of the COVID-19 vaccine. While my intimate involvement with BARDA ceased in 2011, I have no doubt that our early work survives in a top-notch organization which will ensure high quality products.

One other experience is pertinent to the current crisis. One of the contracts our company had with NIAID was the staffing of the Biosafety Level Four (BSL-4) Laboratory at Fort Detrick, Md., one of four such laboratories, the others being in Montana, Boston and Galveston Texas. The mission of BSL-4 facilities involves handing the most dangerous pathogens known to man. All four are part of the National Institute of Allergies and Infectious Diseases (NIAID), headed by Dr. Anthony Fauci, probably the most powerful person in the worldwide public health profession.

The Wuhan Institute of Virology was finally completed in 2015 after ten years in development. Based on various visitors and task assignments, our staff at Fort Detrick had the impression that NIAID was very interested in the Wuhan project – as one might expect in view of the pro-China policies of the US at the time. More recent connections may be more questionable, namely, two contracts executed by NIAID from 2015-2019, totaling $7.4 million for bat-related projects. Whatever the details, it seems likely that Dr, Fauci’s relationship with the Wuhan institute was more than casual.

These past experiences have indeed shaped many of my opinions and positions – and questions — about the current situation.

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